David Vogel
Lake Cormorant
Summary
Experienced Senior Training & Development Specialist with a focus on designing impactful training programs for regulated industries. Over 15 years of success in developing learning solutions that drive compliance and enhance organizational effectiveness. Recognized for improving onboarding and transforming training operations to meet audit standards. Demonstrated ability to partner with teams to close skill gaps and elevate business performance.
Overview
18
18
years of professional experience
1
1
Certification
Work History
Sr. Training and Development Specialist
Olympus Corporation
06.2024 - 11.2025
- Designed and deployed role-based training programs aligned with organizational goals, operational risks, and quality requirements.
- Facilitated training on Audit Readiness, compliance requirements, management responsibilities, onboarding, and system training.
- Ensured all training records, documentation, and LMS activities were audit-ready and compliant with FDA and ISO standards.
- Collaborated with leadership and cross-functional teams to identify training gaps and develop targeted learning solutions.
- Measured training effectiveness using evaluations, assessments, and KPIs to refine learning strategies.
- Built comprehensive, tiered, and blended quality learning strategies for employees across Olympus.
- Created a comprehensive user guide for the training team, providing clear troubleshooting steps and standardized guidance to support Olympus employees with a wide range of training-related issues.
- Managed the training support inbox and served as the primary point of contact for employee training inquiries, resolving issues through detailed email support and live troubleshooting via Microsoft Teams as needed.
Sr. Quality System Specialist
Medtronic, Inc.
01.2010 - 01.2023
- Led Corrective and Preventive Actions (CAPA) including containment, root cause analysis, corrective actions, and effectiveness verification; provided status updates to CAPA Board and maintained documentation in the CAPA system.
- Developed and authored processes, procedures, and quality documentation ensuring compliance with cGMP, ISO 13485, VAWD, and Medtronic quality standards.
- Performed equipment and process validations, ensuring compliance with regulatory and internal quality requirements.
- Served as Subject Matter Expert (SME) for discrepant material systems; created SOPs for detection, segregation, evaluation, and disposition of nonconforming material.
- Led integration of a new Quality Management System during distribution center transition, ensuring operational continuity and compliance.
- Drove the successful initiative to achieve VAWD certification for the distribution center, including writing, reviewing, and updating VAWD-required procedures.
- Managed Service Incident Reports (SIRs) — researched, documented, trended, and escalated distribution-related issues to drive resolution and risk mitigation.
- Defined, implemented, and validated quality and system requirements in alignment with corporate QMS.
- Acted as Quality SME for U.S. Distribution Centers, supporting daily operations and long-term quality strategy.
- Developed and maintained quality directives, policies, processes, and metrics, ensuring alignment with Medtronic’s global QMS.
- Served as the Quality Lead for corporate acquisitions, managing onboarding, integrating acquired companies into Medtronic’s QMS, and aligning procedures and training.
- Planned and executed internal quality audits and third-party supplier audits, preparing documentation and leading follow-up actions.
- Inspected and evaluated discrepant materials; authored Nonconforming Material Reports (NCMRs), established metrics, and ensured accurate disposition and corrective actions.
- Created and implemented the Quality onboarding playbook for new acquisitions to ensure consistent training and compliance expectations.
- Facilitated development of product and process competency through tailored quality training programs.
- Designed and updated QMS processes, including process flow mapping, identifying improvement opportunities, and streamlining workflow efficiencies.
Regulatory Compliance Specialist - Onsite Contractor
Smith & Nephew
06.2009 - 12.2009
- Participated in cross-functional review of compliance reports related to a product recall, ensuring full FDA regulatory adherence.
- Investigated and evaluated patient complaints and injury reports for the Exogen Medical Device Unit.
- Entered complaint and patient data into LAWTRAC, ensuring accuracy and completeness.
- Monitored patient progress and initiated follow-up actions to ensure safety and compliance.
Project Manager/Technical Writer – On-Site Contractor
St. Jude Children’s Research Hospital
05.2008 - 05.2009
- Led the implementation of new departmental software (including MS Project Manager) including user testing, training material development, and user documentation.
- Created user guides, SOPs, training resources, and evaluation tools to support adoption and compliance.
- Managed departmental project work plans, schedules, documentation, and stakeholder communications.
- Developed presentations, reports, surveys, and website updates for the Hematology Department.
Education
Bachelor of Science - Communications
East Carolina University
Greenville, North Carolina01.2001
Skills
- Learning Systems & Platforms: Cornerstone OnDemand, Saba, SuccessFactors, LMS Administration
- Enterprise & Quality Systems: SAP, Agile, Documentum, JDE EnterpriseOne, TrackWise, SiteBuilder, Everbridge, SharePoint, and eMAS
- Regulatory & Quality Standards: FDA QSR, cGMP, MDR, EU MDR, ISO 13485, ISO 14971, ISO 9000/9001, 21 CFR 210/820
- Quality & Process Tools: FMEA / PFMEA, Root Cause Analysis (5 Whys, Fishbone), Document Control
- Certifications: Six Sigma Yellow Belt, ASQ Certified Quality Auditor (CQA)
- Productivity Tools: Microsoft Office Suite
Certification
- ASQ Certified Quality Auditor (CQA)
- Six Sigma Yellow Belt
Non Technical Attributes
- Excellent written and verbal communication skills
- Strong ability to work independently or collaboratively in cross-functional teams
- Advanced analytical and statistical reasoning skills
- Highly organized with strong interpersonal and problem-solving abilities
- Proven leadership with strong coaching, mentoring, and staff development experience
- Effective liaison between project owners, SMEs, leadership, and cross-functional stakeholders
- Strong decision-making ability with a continuous improvement mindset.
Timeline
Sr. Training and Development Specialist
Olympus Corporation
06.2024 - 11.2025
Sr. Quality System Specialist
Medtronic, Inc.
01.2010 - 01.2023
Regulatory Compliance Specialist - Onsite Contractor
Smith & Nephew
06.2009 - 12.2009
Project Manager/Technical Writer – On-Site Contractor
St. Jude Children’s Research Hospital
05.2008 - 05.2009
Bachelor of Science - Communications
East Carolina University